Combat related trauma is significantly affecting U.S. military veterans compared to other military populations across the globe. As many as 20 percent of the U.S. military veterans who served in Iraq and Afghanistan and up to 30 percent of those who fought in the Vietnam War will suffer from Post-Traumatic Stress Disorder (PTSD) in a...
There is a significant unmet need for medications for addictions, chronic, relapsing disorders that lead to biological and behavioral changes that can have harmful medical and psychological consequences. Addictions are common, debilitating and costly disorders resulting in more than $740 billion a year in increased healthcare costs, crime, and lost productivity. Multiple medications have been...
For the estimated 30 million people worldwide who have Alzheimer’s disease, progress toward understanding and treating this most prevalent form of dementia is frustratingly slow. The few approved drugs address only the condition’s symptoms, though scores of drugs to prevent onset or alter the disease’s course are now under study. From high screen failure rates...
We worked on a Phase II study of a drug to treat Fragile X syndrome that, like most rare work we do, was a challenge from the start. Fragile X is a rare and not fully understood genetic disorder, typically resulting from an expansion of the CGG triplet repeat within the Fragile X mental retardation 1 (FMR1) gene...
DURHAM, N.C., SEPTEMBER 5, 2017 — Sponsors and CROs can forge stronger relationships by pursuing long-term partnerships that value collaboration over transactions. Premier Research’s top neuroscientist will discuss how when she hosts a session at Outsourcing Clinical Trials New England in Boston. Krista Armstrong, Vice President and Head of Neuroscience, will describe best practices for...
This is the third installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Additional posts in the series can be accessed here. Solutions to the placebo problem require an understanding of the underlying mechanisms. Broadly, research on contributors to the placebo response falls into two...
This is Part Two of our series on the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Read the other parts here. Analgesic and psychiatric drug development is facing an enormous problem: rising placebo responses in randomized controlled trials (RCTs) threaten the ability of pharmaceutical companies to successfully identify novel...
Sponsors often face significant challenges in collecting robust, quality data that demonstrates the safety and efficacy of investigative psychiatric drugs. However, before these problems can be solved, they must be understood. Be sure to keep these four issues in mind when mapping out strategies for ensuring quality data collection in psychiatric clinical trials. 1. There...
Neurodegenerative disorders present some of the biggest challenges in planning and conducting clinical drug trials. Identifying strategies to proactively address or mitigate these challenges can help to ensure a successful trial. Since the first drugs for neurodegenerative diseases (NDDs) were approved in the 1990s, an increasing number of disease- modifying therapies have been approved for...
Sponsors of psychiatric clinical trials may face significant challenges in collecting robust, quality data to support the efficacy and safety of investigative compounds. Identifying and mitigating study design-, subject-, and site-related factors that may influence data quality as early as possible in program development can help to drive study success. Ensuring that psychiatric clinical trial...